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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No deficiencies.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
no
GLP compliance:
no
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium hypochlorite
EC Number:
231-668-3
EC Name:
Sodium hypochlorite
Cas Number:
7681-52-9
Molecular formula:
ClO.Na
IUPAC Name:
sodium hypochlorite
Details on test material:
Sodium hypochlorite
content (as Cl-): 6.6 %

Test animals

Species:
mouse
Strain:
other: ddY
Sex:
male
Details on test animals or test system and environmental conditions:
Source: Shizuoka Agricultural Cooperative Association for Laboratory Animals, Shizuoka, Japan)
8 weeks old
weight not stated

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Saline
Details on exposure:
Number of applications: 1 and 4

Duration of treatment / exposure:
single injection
Frequency of treatment:
Interval between applications: 24 hours
Post exposure period:
24 hours
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
312.5, 625, 1250 or 2500 mg/kg bw
Basis:
nominal conc.
sigle dose test
Remarks:
Doses / Concentrations:
300 mg/kg bw
Basis:
nominal conc.
four-doses test
No. of animals per sex per dose:
6
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
Clinical signs: No
Tissue : Bone marrow
Details of tissue and slide preparation:
Number of animals: all animals
Number of cells: 1000
Time points: 24 hours
Type of cells: erythrocytes
Parameters: micronucleated polychromatic erythrocytes, polychromatic/total erythrocytes ratio

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
There was no sign of genotoxicity under the conditions described in the study.

Any other information on results incl. tables

Results of the micronucleus test with sodium hypochlorite in mice

Dose

MNPCE [%]

PCE [%]

Mortalities

0

0.17 ± 0.16

56.7 ± 14.8

0/6

312.5

0.20 ± 0.09

61.3 ± 3.8

0/6

625

0.22 ± 0.20

56.2 ± 9.8

0/6

1250

0.17 ± 0.08

29.3 ± 11.8

0/6

2500

-a

-

6/6

positive controlb

3.77 ± 1.08

47.7 ± 18.9

0/6

300c

0.17 ± 0.12

47.3 ± 9.8

0/6

MNPCE              micronucleated polychromatic erythrocytes

PCE                     polychromatic erythrocytes

a                           Not evaluated due to mortalities

b                           2.0 mg/kg bw Mitomycin C

c                           4 doses of 300 mg/kg bw each, 24 hours spacing

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
There was no sign of genotoxicity under the conditions described in the study. For details please refer to Table.
Executive summary:

Groups of eight weeks old, male ddY mice were intraperitoneally administered a single dose of sodium hypochlorite at concentrations of 0, 312.5, 625, 1250, 2500 mg/kg bw in a first test run. In a second trial 4 doses of 300 mg/kg bw spaced by 24 hours were similarly administered. The animals were killed by cervical dislocation 24 hours after the (last) administration. Femoral marrow cells were flushed out with foetal bovine serum and smeared on clean glass slides. Cells were fixed and stained with Giemsa. 1000 polychromatic erythrocytes were scored using a light microscope and the number of micronucleated polychromatic erythrocytes was recorded. The proportion of polychromatic erythrocytes among the total erythrocytes was also evaluated by observing 1000 erythrocytes on the same slide.

There was no sign of genotoxicity under the conditions described in the study. For details please refer to Table.